Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03977181 |
| Other study ID # |
R01MH114648 |
| Secondary ID |
1R01MH114648 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 26, 2018 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
June 2022 |
| Source |
Foundation for Professional Development (Pty) Ltd |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators aim to 1) speed up access to and delivery of PrEP to young women, and 2)
compare interventions to support and maximize the prevention-effective use of PrEP.
Specifically, the investigators aim to answer the following two questions: 1) how can the
study use existing community-based platforms to identify and deliver PrEP to those in need?
and 2) which adherence support interventions are most likely to engender effective use of
PrEP? The investigators propose to answer these questions by leveraging existing
community-based HIV testing platforms in South Africa and use a mixed methods approach to
optimize the PrEP cascade and evaluate a community-based PrEP adherence program for young
women.
Description:
Worldwide, about 1.9 million people became infected with HIV in 2015, most of whom live in
Southern and East Africa. In South Africa, the HIV incidence rate among young women ages
15-24 (2.5%) is four times higher than their male counterparts (0.6%). Recent HIV prevention
trials in South Africa documented incidence rates of 5-6% per year in 15-24 year old young
women. Given this high incidence of HIV, implementing effective HIV prevention strategies -
including PrEP - is crucial to controlling HIV globally.
The proposed study leverages existing community-based HIV counseling and testing platforms in
South Africa and evaluates, using a mixed methods approach, a community-based PrEP adherence
program for young women whilst optimizing the PrEP cascade. Numerous barriers have been
described that delay or block young women from accessing clinic-based health services,
especially reproductive health and HIV testing and prevention services. Consequently,
reaching young women at large scale with HIV prevention services requires delivery platforms
outside of clinic-based facilities. Community-based counseling and testing programs have
shown the greatest coverage and potential to achieve high levels of knowledge of HIV
serostatus and linkage to HIV care. Using community-based counseling and testing programs,
this proposal will deliver PrEP as part of a population-level combination prevention program,
which is necessary to substantially reduce HIV incidence.
The investigators propose to answer key research questions through the following; Specific
Aims: 1) Assess young women's uptake of PrEP when delivered through large-scale
community-based HIV counseling and testing platforms in urban and rural settings in South
Africa, 2) Evaluate community-based scalable interventions to achieve prevention-effective
adherence to PrEP among young women, and 3) Evaluate the cost per young woman initiated on
PrEP and provided adherence support through community-based platforms, and the
cost-effectiveness per incident HIV infection averted. In order to achieve Aim 1, the study
will leverage from on-going, at-scale CBCT programs and platforms (mobile unit and systematic
home-based testing) to identify and link young women to community-based PrEP initiation
services. In order to achieve Aim 2, the study will perform a 3-arm randomized controlled
trial, with participants randomized to one of the following arms: Arm 1) a group-based
community health club akin to an ART adherence club; Arm 2) one-on-one adherence counseling
and support; Arm 3) community-based medication dispensary.
